The current study has two aims. Firstly, to investigate the effectiveness and cost-effectiveness of 8 weeks of the E-health program, Featback, in comparison to Featback with online support from an expert patient, online support from an expert…
ID
Source
Brief title
Condition
- Eating disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be eating disorder psychopathology (as
measured by the Eating Disorder Examination Questionnaire: EDE-Q).
Secondary outcome
Secondary outcome measures will be experienced social support, self-efficacy,
symptoms of anxiety and depression, motivation to change, user satisfaction,
compliance and help-seeking attitudes and behaviors.
Background summary
Many individuals with eating disorder (ED) symptoms do not receive appropriate
mental health care. E-health may help to decrease the time between onset of
symptoms and seeking help. Featback, an internet-based self-help program,
offers a personalized intervention and exist of psycho-eductation, an automated
monitoring and feedback system, and digital support. In the current study,
support will be executed by expert patients. Peer support by expert patients
(or *experts by experience*; in Dutch: *ervaringsdeskundigen*), who have a
self-evident credibility, may improve the self-efficacy of individuals with EDs
and improve outcomes in terms of eating disorder psychopathology and
experienced social support. Earlier research indicates Featback to be effective
in reducing ED symptomatology and suggests that Featback can help with early
detection and intervention for individuals with eating problems.
Study objective
The current study has two aims. Firstly, to investigate the effectiveness and
cost-effectiveness of 8 weeks of the E-health program, Featback, in comparison
to Featback with online support from an expert patient, online support from an
expert patient without Featback, and a waiting list control condition.
Secondly, to investigate moderators of intervention response to explore what
intervention works for which individuals.
Study design
This study will be a randomized controlled trial with a two-by-two factorial
design with repeated measures. The four conditions will be 1) E-health program
Featback, 2) weekly support by an expert patient, 3) Featback with weekly
support by an expert patient, and 4) a waiting list. Condition 1 comprises of
self-guided psychoeducation and a fully automated self-monitoring and feedback
system. Four important dimensions of EDs are assessed weekly, namely excessive
concerns with body weight and shape, unbalanced nutrition and dieting, binge
eating, and compensatory behaviors. After completion, a supportive feedback
message will be automatically generated, which addresses their reported status
(healthy or unhealthy range) and patterns of change (improved, deteriorated or
unchanged) on each of the above-mentioned dimensions. In condition 2
participants can schedule a weekly appointment with an expert patient. For each
session, participants can choose to receive support via chat of e-mail.
Participants in condition 3 will receive the Featback intervention and the
weekly individual support by an expert patient as described above. In condition
4 participants will be placed on a waiting list for 14 months, after which they
will be offered 8 weeks of Featback with support by an expert patient.
Participants will be assessed at pre-intervention (T0), post-intervention (T1)
and at 3 (T2), 6 (T3), 9 (T4) and 12 month follow-up (T5).
Intervention
N.a.
Study burden and risks
Participants do not have to disclose any personal information to participate in
the study, which guarantees confidentiality and anonymity. Participants are
asked to complete questionnaires at baseline, a weekly monitoring questionnaire
during the intervention and a three-monthly questionnaire during the follow-up
phase, which has been found to be an acceptable burden by the client panel.
Earlier research with a similar design showed no adverse effects of Featback
and participants in all conditions, including the waiting list, are allowed to
seek treatment outside the study.
Sandifortdreef 19
Leiden 2333ZZ
NL
Sandifortdreef 19
Leiden 2333ZZ
NL
Listed location countries
Age
Inclusion criteria
1) 16 years or above
2) Access to the internet
3) At least mild self-reported eating problems as indicated by
- Score 52 or higher on the Weight Concern Scale, or...
- One or more of the following symptoms as assessed by the Short Evaluation of Eating Disorders: i) a BMI lower than or equal to 18.5, ii) one or more binge eating episodes a week over the past four weeks, iii) one or more compensatory behaviors a week over the past four weeks
Exclusion criteria
None
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64553.058.18 |